metastatic castration resistant prostate carcinoma (mCRPC) MedDRA version: 20.0 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic System Organ Class: 100000004864
Conditions
Sponsors
AZIENDA SANITARIA OSPEDALIERA S.CROCE E CARLE CUNEO
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Hystologically confirmed mCRPC - Metastatic disease previously treated with at least two lines of different systemic therapy. - Measurable disease (RECIST criteria). - At least one metastatic site suitable for irradiation. - Signed informed consent. - Geographical accessibility. - Age >18 y.o. - Karnofsky P.S. ¿ 60(attachment 1). - Life expectancy > 3 months. - Adequate bone marrow function (Absolut Neutrophil count ¿¿1,5 x 109/l, platelets ¿¿100 x 109/l, hemoglobin ¿¿10 g/dL). - Adequate liver function: transaminases = 2.5 x upper limit of normality (ULN); bilirubin = 1.5 x ULN. - Adequate renal function: Creatinine = ULN or creatinine clearance > 60 mL/min (Cockroft-Gault). - Fertil men must be using adequate contraceptive measures throughout the study period and for up to 6 months after the last dose of study treatment if their partner are women of childbearing potential. - Adequate cardiac function (LVEF ¿ 50% evacuate by MUGA Scan or Echocardiography) . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - History of malignant disease (with the exception of non-melanoma skin tumours) in the preceding five years. - Prior organ transplantation. - Brain metastasis. - Autoimmune or allergic disorders. - Prior treatment with IL-2. - Previous HBV or HCV infections. - Active steroid therapy. - Any active infection requiring specific treatment (Antibiotics, antimicotic, antiviral). - Radiotherapy within 6 weeks before enrollment. - Other non-malignant uncontrolled systemic diseases or social conditions that would preclude trial entry in the opinion of the investigator. - IL-2 treatment contraindications: 1. Hypersensitivity to the active ingredient or to any excipient. 2. Inadequate bone marrow function: WBC <2900 mm3 and/or HCT <30% and/or platelets count <90000 mm3. 3. Uncontrolled serous effusions (pleural, pericardic or peritoneal) 4. Blood Pressure <60 mmHg. 5. Pregnancy or breast feeding. 6. Active infections. 7. Brain metastases. Cyclophosphamide treatment contraindications: 1. Cystitis. 2. Urinary Obstruction. 3. Inadequate bone marrow function: WBC <2900 mm3 and/or HCT <30% and/or platelets count <90000 mm3. 4. Active infections. 5. Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate;Secondary Objective: Toxicity QoL Progression Free Survival (PFS) Overall Survival (OS) ;Primary end point(s): Objective response rate;Timepoint(s) of evaluation of this end point: during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity; QoL; Progression Free Survival; Overall Survival;Timepoint(s) of evaluation of this end point: during treatment and during 4 weeks after the end of treatment; every cycle and at the end of treatment; from study entry to first documented disease progressione or Death from any cause wichever occurred first; from study entry to Death from any cause | — |
Countries
Italy
Contacts
Public ContactUFFICIO SPERIMENTAZIONI CLINICHE
AZIENDA OSPEDALIERA S. CROCE E CARLE DI CUNEO
Outcome results
None listed